Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)

Completed

• Conditions: Ventricular Tachyarrhythmias

• Registration Number: NCT01492764
• Lead Sponsor: University of California, San Diego

Brief Summary

This study will test the hypothesis that many human heart rhythm disorders are caused by small localized sources, where brief ablation may successfully eliminate the heart rhythm disorder.

Detailed Description

The investigators will enroll patients with documented rapid heart rates from the bottom chambers of the heart (ventricular tachyarrhythmias).

During electrophysiological study, the investigators will map the localized sources of these heart rhythm disorders.

1. The 'active' group will prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).

2. The control group will be a historical cohort who have received traditional ablation for this disorder.

All patients will be followed for up to 1 year to ensure that they have no recurrent arrhythmias.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-15
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Documented ventricular tachyarrhythmias.
2. Undergoing clinically indicated EP study with ablation.

Exclusion Criteria

1. Unwillingness or inability to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety of ventricular basket mapping in patients undergoing ablation	1 month	To assess the incidence of adverse events arising from ablation using basket mapping in the ventricles. These include but are not limited to stroke, systemic thromboembolism, MI or acute coronary syndrome, groin complications, or death.
reduction in ventricular tachyarrhythmias events	3 months	Using careful clinical monitoring, we will compare the burden of VT/VF after ablation (including FIRM) to the burden preceding ablation.

Trial Locations

Locations (2)

University of California, San Diego Medical Center; 🇺🇸 San Diego, California, United States

Veterans Affairs San Diego Medical Center; 🇺🇸 San Diego, California, United States